Phase 3 trial of oral PCSK9 inhibitor enlicitide in hypercholesterolemia reports no results

A phase 3 randomized controlled trial, sponsored by Merck Sharp & Dohme LLC, enrolled 301 adults with hypercholesterolemia. The study compared the investigational oral PCSK9 inhibitor enlicitide (MK-0616) to active comparators: ezetimibe, bempedoic acid, or the combination of ezetimibe and bempedoic acid. The primary efficacy endpoint was the mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at day 56, with a median follow-up of 7.3 months. The study setting was not reported.

No numerical results for the primary or any secondary outcomes are provided in the available text. The mean percent change in LDL-C, effect sizes, absolute numbers, p-values, and confidence intervals are all listed as 'not reported.' The direction of any effect (e.g., superiority or non-inferiority) is also not stated, despite the study's aim to assess superiority.

Safety and tolerability data are absent. The reporting does not include rates of adverse events, serious adverse events, or treatment discontinuations. Key limitations cannot be assessed from the provided information, as the core trial results are missing. The practice relevance is noted as 'not reported.'

This summary is based solely on a structured trial record indicating the study is completed. Without access to the actual results, no conclusions regarding the efficacy, safety, or potential clinical role of enlicitide can be made. The findings highlight the critical need for full, transparent publication of clinical trial data to inform evidence-based practice.